Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK), a commercial-stage
biopharmaceutical company focused on the development and
commercialization of innovative therapeutics, announced today that
the Department of Health and Human Services (HHS), Office of the
Assistant Secretary for Preparedness and Response (ASPR), and
Biomedical Advanced Research and Development Authority (BARDA) has
awarded the Company a 5-year contract, with an option to extend to
10-years, to support the development of Paratek’s NUZYRA®
(omadacycline) for the treatment of pulmonary anthrax, FDA
post-marketing requirements (PMR) associated with the initial
NUZYRA approval, and the option to procure up to 10,000 treatment
courses of NUZYRA for the Strategic National Stockpile (SNS) for
use against potential biothreats.
BARDA’s Project BioShield program was created to accelerate
the research, development, purchase, and availability of effective
medical products against chemical, biological, radiological, or
nuclear agents. Project BioShield provides the government with the
authority and funding to develop, acquire, stockpile, and
distribute the medical products needed to protect the United States
against biothreats.
“BARDA is encouraged by the opportunity to partner with Paratek
Pharmaceuticals to further develop this critical antibiotic that
will help us to combat antimicrobial resistance and treat anthrax
infections,” said Dr. Rick Bright, BARDA Director and Deputy
Assistant Secretary for Preparedness and Response. “This award is
an important step in BARDA’s efforts to enhance our national health
security preparedness.”
Under the terms of the agreement, BARDA will award initial
funding of approximately $59 million for the development of NUZYRA
for the treatment of pulmonary anthrax and the purchase of an
initial 2,500 treatment courses of NUZYRA to add to the current
SNS. The contract provides for additional potential time-based
funding including: approximately $77 million for existing FDA PMR
commitments scheduled to begin in April 2020 and approximately $20
million for manufacturing-related requirements scheduled to begin
in June 2020. The remaining staged, milestone-based funding
includes the potential for approximately $13 million to support the
development of NUZYRA for the prophylaxis of anthrax and a maximum
of approximately $115 million to provide for three additional
purchases of NUZYRA for the SNS, each of which will be triggered
upon development milestones related to the anthrax treatment
development program.
NUZYRA is a broad spectrum, once-daily oral and intravenous (IV)
modernized tetracycline that was approved in October 2018 to treat
community-acquired pneumonia and skin infections.
“We would like to thank BARDA, ASPR, and HHS for their
commitment to this innovative and long-term private-public
partnership recognizing Paratek’s commitment to studying NUZYRA in
the treatment and prophylaxis of anthrax. Through Project
BioShield, BARDA has identified and validated the important role
that Paratek and NUZYRA will play in helping to enhance the
biodefense preparedness of our country, saving lives and protecting
Americans,” said Evan Loh, M.D., CEO of Paratek. “Paratek has been
studying the potential utility of antibiotics against bioterrorism
threats for over a decade. Through these activities, we have
generated promising in vitro and in vivo animal data with NUZYRA
against select biothreat pathogens. For these reasons, we believe
that NUZYRA is well-positioned to help address potential public
health emergencies at a time when antibiotic resistance is a
growing global threat.”
BARDA is part of the Health and Human Services Office of the
Assistant Secretary for Preparedness and Response and is charged
with preparing the nation for public health emergencies by directly
supporting the development of new antibacterial products. This
project has been funded in whole or in part with Federal funds from
the Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority,
under Contract No. 75A50120C00001.
Conference Call and Webcast
Paratek’s conference call for the BARDA Project BioShield
Contract will be broadcast today, December 18,
2019 at 5:30 p.m. EST. The webcast can be accessed under
"Events and Presentations" in the Investor Relations section of
Paratek’s website at www.ParatekPharma.com.
Domestic investors wishing to participate in the call should
dial: 877-407-0792 and international investors should dial:
201-689-8263. The conference ID is 13697620. Investors can also
access the call
at http://public.viavid.com/index.php?id=137408.
About NUZYRA
NUZYRA (omadacycline) is a novel antibiotic with both once-daily
intravenous (IV) and oral formulations for the treatment of
community-acquired bacterial pneumonia (CABP) and acute bacterial
skin and skin structure infections (ABSSSI). A modernized
tetracycline, NUZYRA is specifically designed to overcome
tetracycline resistance and exhibits activity across a spectrum of
bacteria, including Gram-positive, Gram-negative, atypicals, and
other drug-resistant strains.
Indications and Usage
NUZYRA is a tetracycline class antibacterial indicated for the
treatment of adult patients with the following infections caused by
susceptible microorganisms:
Community-Acquired Bacterial Pneumonia (CABP) caused by
the following: Streptococcus pneumoniae, Staphylococcus
aureus (methicillin-susceptible isolates), Haemophilus influenzae,
Haemophilus parainfluenzae, Klebsiella pneumoniae, Legionella
pneumophila, Mycoplasma pneumoniae, and Chlamydophila
pneumoniae.
Acute Bacterial Skin and Skin Structure Infections
(ABSSSI) caused by the following: Staphylococcus aureus
(methicillin-susceptible and -resistant isolates), Staphylococcus
lugdunensis, Streptococcus pyogenes, Streptococcus anginosus grp.
(includes S. anginosus, S. intermedius, and S. constellatus),
Enterococcus faecalis, Enterobacter cloacae, and Klebsiella
pneumoniae.
UsageTo reduce the development of
drug-resistant bacteria and maintain the effectiveness of NUZYRA
and other antibacterial drugs, NUZYRA should be used only to treat
or prevent infections that are proven or strongly suspected to be
caused by susceptible bacteria.
Important Safety Information
ContraindicationsNUZYRA is contraindicated in
patients with known hypersensitivity to omadacycline or
tetracycline class antibacterial drugs, or to any of the
excipients.
Warnings and PrecautionsMortality imbalance was
observed in the CABP clinical trial with eight deaths (2%)
occurring in patients treated with NUZYRA compared to four deaths
(1%) in patients treated with moxifloxacin. The cause of the
mortality imbalance has not been established. All deaths, in both
treatment arms, occurred in patients > 65 years of age; most
patients had multiple comorbidities. The causes of death varied and
included worsening and/or complications of infection and underlying
conditions. Closely monitor clinical response to therapy in CABP
patients, particularly in those at higher risk for mortality.
The use of NUZYRA during tooth development (last half of
pregnancy, infancy and childhood to the age of 8 years) may cause
permanent discoloration of the teeth (yellow-gray-brown) and enamel
hypoplasia.
The use of NUZYRA during the second and third trimester of
pregnancy, infancy and childhood up to the age of 8 years may cause
reversible inhibition of bone growth.
Hypersensitivity reactions have been reported with NUZYRA.
Life-threatening hypersensitivity (anaphylactic) reactions have
been reported with other tetracycline-class antibacterial drugs.
NUZYRA is structurally similar to other tetracycline-class
antibacterial drugs and is contraindicated in patients with known
hypersensitivity to tetracycline-class antibacterial drugs.
Discontinue NUZYRA if an allergic reaction occurs.
Clostridium difficile associated diarrhea (CDAD) has been
reported with use of nearly all antibacterial agents and may range
in severity from mild diarrhea to fatal colitis. Evaluate if
diarrhea occurs.
NUZYRA is structurally similar to tetracycline-class of
antibacterial drugs and may have similar adverse reactions. Adverse
reactions including photosensitivity, pseudotumor cerebri, and
anti-anabolic action which has led to increased BUN, azotemia,
acidosis, hyperphosphatemia, pancreatitis, and abnormal liver
function tests, have been reported for other tetracycline-class
antibacterial drugs, and may occur with NUZYRA. Discontinue NUZYRA
if any of these adverse reactions are suspected.
Prescribing NUZYRA in the absence of a proven or strongly
suspected bacterial infection is unlikely to provide benefit to the
patient and increases the risk of the development of drug-resistant
bacteria.
Adverse Reactions
The most common adverse reactions (incidence ≥2%) are nausea,
vomiting, infusion site reactions, alanine aminotransferase
increased, aspartate aminotransferase increased, gamma-glutamyl
transferase increased, hypertension, headache, diarrhea, insomnia,
and constipation.
Drug Interactions
Patients who are on anticoagulant therapy may require downward
adjustment of their anticoagulant dosage while taking NUZYRA.
Absorption of tetracyclines, including NUZYRA is impaired by
antacids containing aluminum, calcium, or magnesium, bismuth
subsalicylate and iron containing preparations.
Use in Specific Populations
Lactation: Breastfeeding is not recommended during treatment
with NUZYRA.
To report SUSPECTED ADVERSE REACTIONS, contact Paratek
Pharmaceuticals, Inc. at 1-833-727-2835 or FDA at 1-800-FDA-1088
or www.fda.gov/medwatch.
Please see full Prescribing Information for NUZYRA at
www.NUZYRA.com.
About Paratek Pharmaceuticals, Inc.
Paratek Pharmaceuticals, Inc. is a commercial-stage
biopharmaceutical company focused on the development and
commercialization of innovative therapeutics. The company’s lead
commercial product, NUZYRA® (omadacycline), which has launched and
is available in the U.S., is a once-daily oral and intravenous
antibiotic for the treatment of adults with community-acquired
bacterial pneumonia and acute bacterial skin and skin structure
infections.
Paratek has entered into a collaboration agreement
with Zai Lab for the development and commercialization of
omadacycline in the greater China region and retains all
remaining global rights.
SEYSARA® (sarecycline) is an FDA-approved product with
respect to which we have exclusively licensed certain rights
in the United States to Almirall, LLC,
or Almirall. SEYSARA is currently being marketed
by Almirall in the U.S. as a new once-daily oral therapy
for the treatment of moderate to severe acne vulgaris. Paratek
retains development and commercialization rights with respect to
sarecycline in the rest of the world.
Recognizing the serious threat of bacterial infections,
Paratek is dedicated to providing solutions that enable
positive outcomes and lead to better patient stories.
For more information, visit www.ParatekPharma.com or follow
@ParatekPharma on Twitter.
Forward Looking Statements This press
release contains forward-looking statements including statements
related to the Company’s award and agreement with the Department of
Health and Human Services (HHS), Office of the Assistant Secretary
for Preparedness and Response (ASPR), Biomedical Advanced Research
and Development Authority (BARDA), our future anticipated funding
and activities and commitments under the award, the study of NUZYRA
in new indications, our overall strategy, products, prospects and
potential. All statements, other than statements of historical
facts, included in this press release are forward-looking
statements, and are identified by words such as "advancing,"
"expect," "look forward," "anticipate," "continue," and other words
and terms of similar meaning. These forward-looking statements are
based upon our current expectations and involve substantial risks
and uncertainties. We may not actually achieve the new indications,
plans, carry out the intentions or meet the expectations or
projections disclosed in our forward-looking statements and you
should not place undue reliance on these forward-looking
statements. Our actual results and the timing of events could
differ materially from those included in such forward-looking
statements as a result of these risks and uncertainties. These and
other risk factors are discussed under "Risk Factors" and elsewhere
in our Annual Report on Form 10-K for the year ended December
31, 2018 and our other filings with the Securities and
Exchange Commission. We expressly disclaim any obligation or
undertaking to update or revise any forward-looking statements
contained herein.
PARATEK® and the Hexagon Logo are registered trademarks of
Paratek Pharmaceuticals, Inc. NUZYRA® and its design logo are
registered trademarks of Paratek Pharmaceuticals, Inc.
CONTACT:
Investor and Media Relations: Ben Strain
617-807-6688 ir@ParatekPharma.com
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